Hard as it is to believe, it’s been nearly a year since I first learned that the Supreme Court agreed to hear a case regarding the legitimacy of the vaccine court. The long version can be found here, but the short version is that last March SCOTUS agreed to hear a case regarding the constitutionality of the law that set up the Vaccine Court back in the 1980s. As you might recall, the National Childhood Vaccine Injury Act was passed in 1986 in order to establish a no-fault compensation system for children who suffer vaccine injury. The NCVIA was necessary because a flood of lawsuits in the wake of a muck-raking, sensationalistic, and, in retrospect, totally inaccurate TV special, Vaccine Roulette, had fired up a fear mongering campaign about the DTP (diptheria-pertussis-tetanus) vaccine to the point where there was a very real danger of pharmaceutical companies in the U.S. giving up on vaccines altogether. The liability had become just too high. Several large jury awards convinced pharmaceutical companies that the risk of producing vaccines was just too high relative to the potential profit.

Due to the fear that litigation might well drive vaccine manufacturers either out of business or leave them no choice but to stop up manufacturing vaccines due to liability concerns, Congress was forced to act. It should be remembered, 25 years later, that these fears were not unfounded. All but one DPT manufacturer stopped manufacturing the vaccine, and the last one was threatening to do so at the time the NCVIA was passed. As I mentioned above, this law established a no fault compensation system for children injured by vaccines. To administer the compensation, the NCVIA established what is now known as the Vaccine Court, administered by the Office of Special Masters in the U.S. Court of Federal Claims. Claims against vaccine manufacturers for vaccine injury can’t be initially filed in state or federal court; they must first go through the Office of Special Masters, where special judges known as Special Masters adjudicate the claims. As a result, the bleeding stopped; the vaccine supply was safeguarded; and parents of children with legitimate injuries caused by vaccines can be compensated fairly rapidly. Indeed, it’s likely that many children who did not have a true vaccine injury were also compensated. This is because the Vaccine Court uses looser rules of evidence and not requiring the Daubert standard for scientific testimony and evidence. Also, there is a list of “table injuries” that are assumed, for all intents and purposes, automatically to be due to vaccines, which is why compensation is more or less automatic for table injuries. Compensation covers medical expenses, legal expenses loss of future earning capacity, and others. Even for unsuccessful claims, legal expenses are often covered. Moreover, claimants can sue in federal court after losing in Vaccine Court. The problem with doing so, however, is that the standard of evidence is more stringent in federal court, and, having lost in Vaccine Court is a very high bar for plaintiffs to overcome. Still, that hasn’t stopped plaintiffs from trying, particularly given that damages for pain and suffering are capped in Vaccine Court.
Then, in March 2010, SCOTUS agreed to hear Bruesewitz v. Wyeth. The case involves Hannah Bruesewitz, who was born in 1991. Hannah received the first three shots of DPT, and after the third injection developed seizures. The parents presented a claim in Vaccine Court, but lost. As a consequence, they decided to sue in Pennsylvania state court for what they argued was a preventable injury due to a “design defect” in the vaccine. Even though the federal Third Circuit Court of Appeals ruled for the vaccine manufacturer in the case, concluding that the legislative history of the NCVIA indicated a clear intent by Congress to preclude suing for claims of preventable injuries due to poor design, the case went to the Supreme Court because vaccine manufacturers and the Obama Administration requested it for clarity. They wanted a ruling once and for all whether the NCVIA preempted lawsuits based on design defect claims in state courts, given that clearly trial lawyers were now trying to bypass the Vaccine Court using such arguments. The case basically boiled down to three questions:

whether the Act preempts all design defect claims against the manufacturer of a vaccine

whether the plaintiffs demonstrated that the manufacturer failed to adequately warn the plaintiffs of the risks associated with the vaccine

whether the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant’s motion for summary judgme

The justices, voting 6-2, said a 1986 federal law preempts claims that a drugmaker should have sold a safer formulation of a vaccine. The law, designed to encourage vaccine production by limiting patient suits, channels most complaints into a company- financed no-fault system that offers limited but guaranteed payments for injuries shown to be caused by a product.

“The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries,” Justice Antonin Scalia wrote for the majority. “In exchange they avoid costly tort litigation and the occasional disproportionate jury verdict.”

The ruling is a victory for the four companies that supply vaccines for the U.S. market — Wyeth, GlaxoSmithKline Plc, Merck & Co. and Sanofi-Aventis SA. A ruling letting the parents sue Wyeth might have allowed suits by thousands of families that say vaccines caused autism in their children. Since 1988, the no-fault process has led to almost $2 billion in compensation to more than 2,500 families.

The issue for the Supreme Court was whether the 1986 law leaves open the possibility that patients can sue manufacturers when the side effects were avoidable. The Obama administration joined Wyeth, acquired in 2009 by New York-based Pfizer, in urging the justices to bar those types of suits.

Courtesy of our “friends” at the anti-vaccine crank blog Age of Autism, you can find the full text of the SCOTUS decision here.Justice Scalia wrote the decision, and Justice Breyer submitted a concurring statement, while Justice Sotomayor wrote the dissent. Basically, it’s a resounding victory for the NCVIA and the Vaccine Court. I will admit to being somewhat concerned about how this case was argued, though. Everything seemed to hinge on whether or not the Vaccine Act (i.e., the NCVIA) completely preempts design defect claims in which it is argued that a vaccine manufacturer could have formulated a safer version of a vaccine. The relevant portion of the NCVIA states:

[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

The case appears to have hinged upon what the intent of Congress was in writing the law, and SCOTUS concluded:

Design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. This lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability. The Act’s mandates lead to the same conclusion. It provides for federal agency improvement of vaccine design and for federally prescribed compensation,which are other means for achieving the two beneficial effects of design-defect torts–prompting the development of improved designs, and providing compensation for inflicted injuries.

In other words, the Vaccine Act excluded design defects by intent. At least that’s how SCOTUS interpreted it. If design defects are to be an exception, Congress will have to amend the law or pass a new law.

Does this mean that there is no recourse for parents who have evidence that their child was injured by vaccines? Certainly, the anti-vaccine movement seems to think so, but, as usual, they go way over the top. For example, right on cue, Louise Kuo Habakus cranked up the fear mongering to 11 in a quote cited in a post over at the anti-vaccine crank blog Age of Autism entitled Court Protects Vaccine Manufacturers, Not Injured Children:

According to vaccine safety advocate Louise Kuo Habakus, “The Court is telling parents that they’re on their own. Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program. The Supreme Court has slammed the courthouse doors shut.” Because the federal government recommends 70 doses of 16 “unavoidably unsafe” vaccines, and states compel 30-45 doses for school attendance, this issue affects all children.

This is, of course, a load of fetid dingos’ kidneys. Not only do parents who think their children have been injured by a vaccine have recourse to the Vaccine Court, where, win or lose, their attorneys’ fees are paid by the government. Then, if they fail in Vaccine Court, they still have recourse to federal courts. Habakus is also parrotting the same anti-vaccine exaggerations, with “70 doses.” What happened to the usual nonsense about “36 vaccines”? Apparently that number isn’t big enough to be as frightening as Habakus wants. In any case, the courthouse doors are in no way “slammed shut.” The Vaccine Court exists. It is intentionally set up to make pursuing claims easier than in state or other federal courts, and the standard of evidence for what scientific evidence may be presented in Vaccine Court is looser than it is in other federal courts. Moreover, there still exists a list of known and possible vaccine injuries for which compensation is virtually automatic. Finally, even if the Vaccine Court denies a claim, as I’ve pointed out, there are still federal courts. The law only mandates that claims for vaccine injury have to go through the Vaccine Court first. Moreover, ask this question: The Vaccine Act states that claimants have to go through the Vaccine Court if “injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” What if the vaccine was not “properly prepared”? What if it was not accompanied by “proper directions and warnings”? Presumably, if that were the case, parents could still bypass the Vaccine Court and sue directly in state or federal court.

Despite their resounding defeat, the anti-vaccine movement can still find a crumb to console itself with in the dissent written by Justice Sonia Sotomayor, which seems to buy somewhat into some of the anti-vaccine arguments, accusing the majority of writing a “policy-driven,” rather than a law-driven, decision:

Respondent notes that there are some 5,000 petitions alleging a causal link between certain vaccines and autism spectrum disordersthat are currently pending in an omnibus proceeding in the Court of Federal Claims (Vaccine Court). Brief for Respondent 56-57. According to respondent, a ruling that Â§22(b)(1) does not pre-empt design defect claims could unleash a “crushing wave” of tort litigation that would bankrupt vaccine manufacturers and deplete vaccine supply. Id., at 28. This concern underlies many of the policy arguments inrespondent’s brief and appears to underlie the majority and concurring opinions in this case.

Actually, she has a point. The law is the law, and it shouldn’t matter how many people are suing based on the law. If the law is producing bad policy, then the law needs to be changed. Here’s where Justice Sotomayor goes off the rails:

Trial courts, moreover, have considerable experience in efficiently handling and disposing of meritless products liability claims, and decades of tort litigation (including for design defect) in the prescription-drug context have not led to shortages in prescription drugs.

What planet is she on? As Sullivan points out, the very reason that the NCVIA was passed and the Vaccine Court created was because of a–dare I say?–tsunami of lawsuits based on claims that the DPT caused neurological injury, claims that were not supported by later studies. The number of manufacturers of vaccines was declining precipitously, raising real fears that the U.S. vaccine system would collapse. Another example is the furor over silicone breast implants, which in the 1980s and 1990s were blamed for autoimmune diseases, cancer, and various other systemic diseases, claims that were later demonstrated by epidemiological studies to be without a scientific basis. The lawsuits based on these claims drove Dow Corning into bankruptcy. No, I’m afraid Justice Sotomayor borders on the delusional when she blithely proclaims that courts are so good at efficiently disposing of meritless product liability claims. Unfortunately, the converse is also true; the courts aren’t so good at efficiently compensating victims suing based on meritorious product liability claims, either.

Perhaps the paragraph in the majority opinion ruling that stands out the most is this one:

These provisions for federal agency improvement of vaccine design, and for federally prescribed compensation, once again suggest that Â§300aa-22(b)(1)’s silence regarding design defect liability was not inadvertent. It instead reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.

Imagine that! Leave the science to scientists, the FDA, and the National Vaccine Program, rather than the juries. What a radical concept! It’s a concept entirely lost on the anti-vaccine movement in general and Mike Adams in particular, who couldn’t wait to chime in either, this time in a typically histrionic screed entitled U.S. Supreme Court denies parents of vaccine damaged children their right to seek justice. One can’t help but chuckle and point out that the parents were so denied justice that they managed to take their case all the way to the Supreme Court of the United States. Here’s a hint, Mike: Just because a SCOTUS decision didn’t go your way doesn’t mean that justice was denied. That doesn’t stop Mike from making some truly disturbing statements, for example:

The vaccine industry is killing children. It is maiming them, destroying their nervous systems and causing permanent harm. These are acts of medical violence committed against children. Even the vaccine court admits this link through its own cash payouts to parents of damaged (or dead) children.

And yet, the U.S. government continues to endorse these acts of violence against children. It even goes so far as to excuse them by providing immunity to the corporations whose products harm these children.

It doesn’t take a genius to realize that this blanket immunity takes away any incentive of safety from the vaccine manufacturers. With no liability, what motivation do they have to improve the safety of their products? They have none. No wonder vaccines continue to be so dangerous, manufactured with mercury, aluminum and formaldehyde among other neurotoxic ingredients.

This entire situation is nothing less than extraordinary. The vaccine industry gets blanket immunity. The government denies parents their Constitutional right to due process. The children continue to be harmed and killed by vaccines, and yet the parents have no means by which they can seek justice.

While Adams has a germ of a point (namely that giving the industry too much immunity might remove incentives for improving vaccine safety), as usual, he takes it straight off the cliff into Crazy Ocean. Adams then goes on to proclaim the vaccine program as “state-sponsored terrorism against children,” after which he wonders what recourse parents now have. His answer is what is disturbing:

This is where acts of violence will no doubt enter the picture. Violence is the last, desperate option for those who have been denied all other options to resolve their grievances peacefully. When the courts, the government and the corporations have conspired against you to harm your children and then deny you any legal recourse, it is only a matter of time before some parent of a vaccine-damaged child decides to take matters into their own hands through acts of violence committed against those who damaged their children.

Do not misinterpret this as an endorse of such actions. NaturalNews has consistently and repeatedly decried the use of violence to resolve problems. Yet we cannot deny that in this legal / pharma / government conspiracy that causes children to be harmed while denying parents any legitimate legal recourse, it is inevitable that angry, disenfranchised parents will sooner or later reach a boiling point and decide to pursue justice in the only way left available to them.

Mike’s not advocating violence, you know, but he understands and is down with the anti-vaccine movement, so much so that he thinks there should be an “uprising” against what he calls the “vaccine state,” just like how the people of Egypt, Libya, and Iran took to the streets to protest tyranny.

Then, while decrying the possibility of violence, which, while claiming he opposes it, Adams spends a lot of time describing and labeling the “vaccine pushers” as having blood on their hands, he concludes:

When the People are suppressed, with their children are maimed by the state, when their rights are denied by the courts, and when they feel as if they have no options remaining to them, they will sooner or later take to the streets with sticks, or stones, or bullets. One way or another, they will seek the justice that has been denied them by the corrupt state, operating in a criminal conspiracy with the vaccine industry.

I pray for America. And I pray for the victims of the vaccine industry. I pray, but I do not dare hope, that this grave injustice can be resolved without eventual bloodshed committed by those who have been driven to desperation by a corrupt, criminally-operated system of medical violence against children.

I can’t help but note that Adams appears to use bold type in the same way that Internet cranks used to use all caps on Usenet. In any case, here’s a hint: We are a nation of laws. The law creating the Vaccine Court was passed constitutionally by our duly elected representative and signed by the President (who, at the time, was Ronald Reagan). SCOTUS has ruled on how the law should be interpreted. Don’t like it? Try to get it changed! Petition your lawmakers. Try to elect anti-vaccine lawmakers to Congress. Engage in democracy. But don’t use thinly veiled, disingenuously denied threats of violence. Besides, if the revolution were ever actually to come, my guess is that Adams would probably be hiding in his home in Arizona and not out there storming the barricades.

In the meantime, the anti-vaccine movement rolled the dice and lost. Big time.

98 Comments

Sorry, Orac, I have to admit to misgivings on this one. This isn’t just about vaccines, but a pattern by the Roberts court of leaning on the side of corporate interests. I’m not sure I want any industry immune from lawsuits.

That sound you’re hearing is one of shifting goalposts, and lots of them. (BTW, I think Dr. Jay called me “Doc”. I am not a doctor [or have a doctoral-level education], and I have never portrayed myself as such. Then again, it could be an artifact of me calling him “Doc” in an earlier tweet.)

This isn’t just about vaccines, but a pattern by the Roberts court of leaning on the side of corporate interests. I’m not sure I want any industry immune from lawsuits.

I agree, Alexis. This is one of the (many, many) reasons why John Edwards would have been a far better president than Barack Obama. As a personal injury trial lawyer himself, he would have been front and center in attacking this anti-tort (which means anti-jury and anti-democratic) ruling.

You can talk about ‘scientific evidence’ until the cows come home, but interpreting evidence is a task for basic logic, and no amount of training or experience in the medical field gives a medical ‘expert’ any benefit with regard to that. I trust the wisdom of twelve ordinary citizens, with no ulterior motives but desire for truth, to determine whether or not someone was actually harmed by vaccines, far more than I do the ‘expertise’ of PhDs bought and paid for by the soulless multinational corporations that operate under the name of ‘universities’ and ‘research hospitals’.

Not too much sarcasm, if you hadn’t included that line in the bottom you would have reeled a few people in. Honestly, given the cranks who show up, I don’t think it is possible to actually make a comment that’s so over the top that it is obviously fake :p

One thing that struck me as I gave the decision a quick readover this morning was the concept that vaccine safety is not really a pure good “safer is better”. It’s more of a delicate balancing act.

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. Striking the right balance between safety and efficacy is especially difficult with respect to vaccines, which affect public as well as individual health.

In at least one case (the oral polio vaccine ??), we’ve actually decided to choose a less effective but safer vaccine.

“Sorry, Orac, I have to admit to misgivings on this one. This isn’t just about vaccines, but a pattern by the Roberts court of leaning on the side of corporate interests. I’m not sure I want any industry immune from lawsuits.”
1. They aren’t immune. The Vaccine Court is a specialized forum which tries a limited range of suits;
2. The burden of proof is lower than in US District Courts trying civil damages suits. If the injury is on the list, causation is presumed and claimant need offer no proof. Most tort suits involving alleged toxic exposure, chemical injury, and similar claims die for inability to provide expert proof meeting Daubert standards to show causation;
3. Even for non-list claims, the burden of proof for admission of expert opinions is lower. In the US District Courts, the courts are to act as gatekeepers to keep out evidence that does not meet certain basic criteria. Meeting that criteria is done via the Daubert standards. In the Vaccine Court, the Special Masters are assumed to have more specialized knowledge and so “expert opinions” are admitted into evidence more readily (Pseudoscience may not be persuasive, but it’s admitted into evidence);
4. Attorneys fees and expert fees are awarded even to the loosing side. This has the effect of keeping them coming back for more. In US District Courts, absent a statute or contract provision providing for awarding of attorneys fees to the prevailing party, each side bears their own attorneys fees. And, in the US District Courts, the court can, and usually does, tax some of the experts’ fees to be paid by the loosing party.
Accordingly, the Vaccine Court is not an unfavorable forum for claimants. However, trial lawyers can’t bamboozle a jury with rhetoric (e.g., John Edwards “channelling” a dead child when alleging that a Ceasarian caused problems that no medical expert opined it could cause — and the jury still awarded over $1Million in damages).

The Vaccine Court can be efficient at the threshold of injuries that it chooses to recognize.

There are good reasons to expect these thresholds to reflect substantial, demonstrable injury which may result in individual families eating a substantial amount of lesser injuries, or offically unrecognized injuries. Previous successes of a particular vaccine can shift the vaccine from hero to exile, e.g. OPV.

There are a lot of institutional integrity problems in the West today, just look at major company scandals and the banks. People have real reason to be skeptical of any proclamations or limitations on liabilities instead of strict liability standards at a lower threshold. Perhaps once drug companies reflected chemical or biological researchers as the dominate culture, much like founding builders and researchers in other industries. Today, sales, incompetent service, averted or blind eyes, and CYA often race psychopathy as corporate standards.

Let the buyer, or parent, be extra aware is not paranoia. It seems to many that uncompensatable layers of injuries may necessarily exist, and the Vaccine Court is not an effective mechanism. Potentially, there are clinically or judicially unrecognized, or subthreshold, vaccine injuries.

Of course, the incentive to be safer is provided by the need to satisfy the FDA. And the success of this approach is demonstrated by the fact that by any rational standard, vaccines are among the safest products of any kind used by consumers.

prn – I’m confused as to your reference to “Western” integrity problems….I seem to remember huge institutional problems in the Japanese banking system, in particular the huge number of bad loans for real estate investments that hobbled their economy for over a decade.

China isn’t exactly playing on the up and up either, with their currency, environmental controls, export & copyright protection policies, etc….so what about “Non-Western” institutions – and please enlighten us as to what those are exactly?

Oh, perhaps our anti-vaxxers were becoming rather disheartened this dreary winter- as Wakefield continues circling the drain- so this’ll liven’em up and give them something to rant about. Spring is in the air!

But about Mike: I read his output and try *very hard* to discern a glimmer that it is merely ad copy- a means to an end, a way to enrich himself by taking advantage of his audience’s decreased capacities and limited education. However, it is *so* banal and pedestrian( with analogies that are absolutely priceless!), I can’t believe for a minute that he isn’t at least *partially* sincere ( if he were a *total* fraud, wouldn’t he at least attempt to present himself more attractively?): Mikey ( master of the single entendre) apparently *believes* this. Null, similarly a believer, invokes the unsavory image of leading his followers to the barricades, rising up against the corruption and oppression that is the government-corporate-WallSt-mainstreammedia-professional-educated-wealthy-elite.

Reading and listening to tripe like this requires both a strong stomach and a resilient psychological makeup: I’m glad that I inherited the latter but sometimes worry about the former. There’s always pepcid.

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one.

I fear that the anti-vaxxers are going to try to get a lot of milage out of this line. Even though the context is provided in the next sentence, and it is of course correct, all they are going to do is jump on how “See? They don’t care about making vaccines as safe as possible!!!!”

If you want “as safe as possible” we could just inject saline solution. It wouldn’t be much of a vaccine (via a hydration mechanism), but hey, it’s safe…

Sotomanure is a remarkably incompetent judge and I am still amazed she was selected for the position over potential candidates likes Judge Richard Posner of the 7th circuit. Her “dissent” reaks of her political motivations and her emotional commitments. Her opinion seems to allude that courts are the proper venue to decide objective scientific matters, discovery a method of knowledge and that the link between autism-vaccines is just around the corner (She writes: “To be sure, those rulings do not necessarily mean that no such causal link exists, â¦ or that claimants will not ultimately be able to prove such a link in a state tort action, particularly with the added tool of civil discovery”).

Obama should be completely ashamed to have appointing such a buffoon to the court. We all knew before the confirmation that she is prone to this sort of behavior (i.e. seeking her own policy ends) rather than the legal matter of objectively applying the clear intent of congress.

To all who complain that this law shields the vaccine manufacturers from tort liability: that is wrong.

If you read the Supreme Court ruling on this matter, it clarifies that vaccine manufacturers are still liable for manufacturing defects, and/or failure to include proper directions or warnings. Only “design defects” are excluded.

Design defects, in this case, basically means side effects that are inherent in the currently approved vaccine “designs”. It is known that certain side effects, although rare, will manifest themselves, and are not due to the vaccine manufacturers wrongdoing. This is similar to saying that allergic reactions are an inherent “design defect” of making peanut butter, thus we’re not gonnna hold peanut butter makers liable for a person having an allergic reaction to the peanuts in it.

The “vaccine court” is only the first step available to parents. If they disagree with that ruling they can always sue the vaccine makers in federal courts.

However, the vaccine court is set up to make it easier for parents and injured persons to get money. For most aknowledged vaccine side effects there is no burden of proof on the plaintif. As long as the effect is one that is recongnized as a side effect of vaccines and it happened within a certain amount of time from receipt of vaccine, monetary reimbursement is automatic. Furthermore, as long as the suit is not frivolous, attorney fees are covered for parents, even if they do not win.

The purpose of the 1986 National Childhood Vaccine Injury Act is not to protect Big Pharma (this protection does not extend to other drugs Big Pharma sells), but it is meant to protect our vaccine supply. It provides a way for injured persons to get money without driving vaccine manufacturers out of the business of making vaccines.

#12, 16. “FDA” and “safety” have long had political dimensions. Vaccines are not “among the safest products of any kind,” they are received on the basis of an overpowering net benefit.

A retrospective look at 20th century vaccine experience might put fatalities closer to sporting ammunition, with ammo possibly being safer on a unit basis, outside of homicidal intent.

#13. This not a West vs East problem, it the West failing internally, a then and now problem. We are failing by previous Western standards, indeed even rewarding “it’s a feature not a bug” types of fraud. Although a lot of cruft was covered up in the past, items of unusual criminal activity 40-50 years ago seem to be commonplace corporate and political activity now.

I am starting to see irrelevant promotion of xenophobia and bait masking informed dicussion here. I may have more direct criticism of China, it is not a factor here, about things we do to ourselves.

Mike Adams: “This is where acts of violence will no doubt enter the picture. Violence is the last, desperate option for those who have been denied all other options to resolve their grievances peacefully…Do not misinterpret this as an endorse of such actions… NaturalNews has consistently and repeatedly decried the use of violence to resolve problems. Yet we cannot deny that in this legal / pharma / government conspiracy that causes children to be harmed while denying parents any legitimate legal recourse, it is inevitable that angry, disenfranchised parents will sooner or later reach a boiling point and decide to pursue justice in the only way left available to them.”

It’s good to know that Mike decries violence, and in no way is egging on antivax crazies to add violence to their usual pattern of deception, fraud and harassment. It’s hard to see how anyone might believe that Mike is encouraging any more deaths of innocent people than the antivax movement is already guilty of, or that he’s gloating at the prospect. His statement of being anti-violence is most welcome and reassuring.

Correct me if I’m wrong, but didn’t Barbara Loe Fisher have something to do with the creation of the vaccine court? I may be wrong, and it is easier to google, but I get my best vaccine/science-based info here. Anyone?

I really don’t care about this decision one way or the other, but I do struggle with the idea that the majority of justices who ruled this case consider themselves to be interpreting the Constitution strictly. Why wouldn’t this be something for states to decide amongst themselves? I’m pretty sure that decisions on who decides ‘complex epidemiological judgements’ aren’t enumerated as a federal power in the Constitution, and because of that, ought to be left to the states; at least according to most of the court who is going to side with Roberts most of the time. (?)

I know it would be chaos and all, but why not just kick this back to the State level? I happen to think that trying to figure out how George Washington would have felt about this issue is ridiculous, but I am bothered by the seeming hypocrisy of the idea that the federal government has the clearly enumerated right to make this decision based on a strict interpretation of the Constitution.

It’s a Federal Court matter because the companies are inter-state, the people making claims against them are from different states, and the appeals process on this particular case moved it up to the Supreme Court, as it should.

No, it’s not expressly mentioned in the Constitution, but neither is privacy… It’s something that is implied. The law is silly like that.

It’s called federal preemption, and it is a explicit power given to Congress by the constitution. Article VI, clause 2 states “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof … shall be the supreme Law of the Land; … any Thing in the Constitution or Laws of any state to the Contrary notwithstanding.”

It is as old as nation. It would be radical judicial activism to claim otherwise. The court merely upheld Congress’ clear intent in this ruling.

To that, I’d add that this ruling specifically addresses the scope of the NCVIA, which is a federal law, and the reach of the Vaccine Court, which is a federal entity. The Supreme Court is the only body with Constitutional competence to issue such a ruling.

Your question seems only to make sense in the context of the simplistic and inaccurate view that this ruling dealt with “whether one can sue vaccine manufacturers.” Please reread.

Correct me if I’m wrong, but didn’t Barbara Loe Fisher have something to do with the creation of the vaccine court? I may be wrong, and it is easier to google, but I get my best vaccine/science-based info here. Anyone?

According to her biography:

While working with Congress to develop the National Childhood Vaccine Injury Act of 1986, led demonstrations at the Centers for Disease Control and the White House that year.

And here is a transcript of testimony that she gave to congress. Here’s a little more detail:

My name is Barbara Loe Fisher and I am co-founder and president of the non-profit organization known today as the National Vaccine Information Center that worked with Congress on the National Childhood Vaccine Injury Act of 1986 … . Along with our organizationâs first president, environmental law attorney Jeffrey Schwartz, who was a principal co-architect of the Act, …

Interestingly, from the same transcript:

We were assured that, unlike a lawsuit in civil court, the federal compensation system would be based on the presumption that a vaccine or combination of vaccines caused the childâs injury or death if no other demonstrated cause could be found.

That is, they thought that the vaccine court would hold the vaccine manufacturers guilty until proven innocent, and I assume they were rather ticked off when this wasn’t the case.

The simple answer to all this nonsense would be if everyone were to come to their senses and realised that vaccination is an absolute fraud and an organised criminal enterprise and consequently refused to submit their babies for these useless but highly toxic shots.

“Belief in immunisation is a form of delusional insanity.”
Dr Herbert Shelton

Since you’ve consistently posted antivax comments here over a long period, it is hard to ascribe indifference on the Supreme Court’s decision to you.

Your proposal to let states “decide for themselves” is akin to anti-abortion rights advocates wanting to overturn Supreme Court protections in favor of a state-by-state hodgepodge – they know that many states would have restrictive antiabortion policies, and that’d suit them just fine.
It’s understandable that you’d like to see at least some states create an easy path to sue vaccine manufacturers out of business. Too bad that won’t be happening.

@ Vaccine Times: you beat me to it with your explanation of the “vaccine court’s” (way) lower burden of proof for awarding of damages and reimbursement for attorney’s fees…as long as the action is not “frivolous”. Hannah’s case before the “vaccine court” did not meet the lowered burden of proof.

I was able to locate the other (lower) court case and ruling against the plaintiff in the United States Court of Appeals for the Third District available at “073794p.pdf” to find out some more details about the case that went to the SCOTUS.

Hannah was born on October 20, 1991 and at the time DPT vaccine was recommended to be administered in a series of three immunizations at ages 2 months-4 months-6 months; booster shots of DPT vaccine were recommended to be administered between 15-18 months of age (#4 DTP) and the #5 Dose of DPT was recommended between 4-6 years old. To figure out “spacing” of immunizations CDC considers a “month” to be 4 weeks af age, 2 “months” is 8 weeks of age and 6 “months” is 24 weeks of age.

In December, 1991 the FDA approved a DTaP vaccine (acellular pertussis rather than whole cell pertussis component) to be used ONLY for the 4th and fifth doses. Six years after that, and after determining that DTaP provided immunity against pertussis in older children, DTaP was approved for all five childhood doses.

Hannah received her third dose of the recommended (TriImmunal)on April 1, 1992 when she was 24 weeks, 2 days old and her parents claimed that she had seizures after the third recommended dose of TriImmunal vaccine. Again this lower court’s ruling was that her case did not reach the burden of proof for seizures caused by immunizations.

Again this lower court’s ruling was that her case did not reach the burden of proof for seizures caused by immunizations.

Given that she had had not just one but two previous rounds of this vaccine, that makes sense. I can see the first causing it, and the second maybe as an allergic response, but nothing until the third? Good reason to be skeptical of that claim.

@2 Orac wrote: If you think this law makes the vaccine industry immune from lawsuits, you are misinterpreting the law.

Have to disagree with you. That will come as a shock to my many fans at Huffington-Post who get incensed when I make references to the great and powerful Orac.

In practice, the decision will end the lawsuits. Because without the design argument, all that is left is the the vaccine is made improperly argument. And in the absence of evidence that vaccines were made improperly, lawyers won’t take on the cases.

Vaccine makers have a very powerful incentive to come clean on any problems with their vaccines. If they admit problems, compensation will be made through the vaccine court and it almost certainly won’t go to a lawsuit. In a lawsuit, they are protected from punitive damages. http://www.law.cornell.edu/uscode/42/usc_sec_42_00000300–aa023-.html

If they try to hide problems, then they are liable for punitive damages in a lawsuit.

So vaccine makers will come clean with problems — if they are silent, that’s very, very good reason to believe there was nothing wrong with the vaccine. So plaintiff’s lawyers are just not going to take on these cases.

Orac, I, like you, was concerned about Sotomayor’s dissent. Besides any possible antivaxxer sympathy she had, it was clear that she either did not understand or else refused to accept Congress’ intent with the law in 1986. Her claim that this meant vaccine makers now did not face regulation? If she really thinks that, that’s scary as hell. http://socraticgadfly.blogspot.com/2011/02/antixvaxxers-lose-another-one.html

Otherwise, I agree on the design defect issue. Or, if the law is generally thought too loose. Congress has the right, or even duty, to amend it.

No, it’s not expressly mentioned in the Constitution, but neither is privacy… It’s something that is implied.

That’s my point, exactly, though. The guys that voted for this, guys like Scalia, don’t think that the right to privacy is in the Constitution!. He argued this in a dissent in a planned parenthood suit.

The States may, if they wish, permit abortion on demand, but the Constitution does not require them to do so. The permissibility of abortion, and the limitations upon it, are to be resolved like most important questions in our democracy: by citizens trying to persuade one another and then voting

That’s what’s bugging me here; the same people who think that there is no implicit right to an abortion to be federally mandated, think vaccination should be.

It isn’t strict at all; it used to be strict in Washington’s day, when most people never ever left their state. But by today’s standards, damn near everything we purchase has travelled across state lines. This means that the federal government has purvew over anything bought and sold unless it originated, and is consumed with a state border. That’s pretty much nothing. That isn’t the type of thing you’d expect justices who traditionally consider themselves interested in restricting federal power as being on board with.

@Dangerous Bacon –

Your proposal to let states “decide for themselves” is akin to anti-abortion rights advocates wanting to overturn Supreme Court protections in favor of a state-by-state hodgepodge – they know that many states would have restrictive antiabortion policies, and that’d suit them just fine.

But this is exactly what guys like Scalia believe the Constitution enables, and nothing more! That’s what makes this so hyproctirical! Repeating from his views on the issue.

The States may, if they wish, permit abortion on demand, but the Constitution does not require them to do so. The permissibility of abortion, and the limitations upon it, are to be resolved like most important questions in our democracy: by citizens trying to persuade one another and then voting

That’s not me, that’s Justice Scalia, a guy who voted with the majority.

It’s understandable that you’d like to see at least some states create an easy path to sue vaccine manufacturers out of business. Too bad that won’t be happening.

This is similar to saying that allergic reactions are an inherent “design defect” of making peanut butter, thus we’re not gonnna hold peanut butter makers liable for a person having an allergic reaction to the peanuts in it

The only difference is that the government isn’t pushing and forcing peanut butter on its citizens

Possibly the reason that Justice Scalia views vaccination and abortion differently is that he sees the former as a vital component of public health policy, while abortion rights are something the states can slice and dice at will.

That would be an imperfect rationale from my viewpoint, but you take what you can get.

Then again, I’m not, as you profess to be, someone with no overriding interest in vaccination who’s entirely focused on logical and consistent jurisprudence. 😉

The Advisory Committee on Immunization Practices (ACIP) is presently meeting today and session continues through tomorrow. Live stream coverage of their meeting are available at their website.

CDC states that 21,000 cases of pertussis were reported in 2010 including at least 26 deaths. California had a disproportionate number of reported cases (8,300) including 10 infant deaths attributed to pertussis

Until Mike stated that he doesn’t encourage violence, I had thought that was exactly what he was doing. I can only assume that any violence would be similar to that of pro-life groups in which case extremist anti-vaxers will eventually get their chance against a jury albeit in a criminal case not civil. Hopefully common sense will prevail.

Until Mike stated that he doesn’t encourage violence, I had thought that was exactly what he was doing.

He’s just doing what the anti-choice folk do in regards to anyone having a connection to abortions – “I’m not encouraging violence, but doesn’t this situation call for violence?” Then, when violence occurs, “We had nothing to do with that, we condemned violence! (And it’s too bad the person the violence was perpetrated against acted in such a way as to make this happen…)”

That’s what’s bugging me here; the same people who think that there is no implicit right to an abortion to be federally mandated, think vaccination should be.

Except that abortion is not for the common good, while vaccination is. There is plenty of legal precedent (from SCOTUS) that you should be compelled to receive a vaccine or, at least, not be allowed a philosophical exemption. Dr. Offit told us about it in Philly, and I wrote about that speech here.

@ Cerise : Mikey has to be *very careful* about what he says publicly- for the last 2 years or so he has been rabble rousing like a mad tea-partier, talking “health freedom” contra the government, “fighting back”, ad nauseum-*then* soon after he moves back to Tucson, the unfortunate attack on Rep. Giffords and the other victims takes place practically in his own back yard. Vitriolic speech by others such as Palin, Angle, etc.(& FOX TV) was then condemned by most rational people. He has to at least *say* that he’s against violence, while he fans the flames of anger. And talks out of both sides of his mouth.

He may not have a brain in his head but he certainly doesn’t want to be percieved in too a negative a light : it might affect sales; he owns his several companies.

From #5:” This isn’t just about vaccines, but a pattern by the Roberts court of leaning on the side of corporate interests. I’m not sure I want any industry immune from lawsuits.”

I had this concern too as I was reading this. But then I remembered we don’t live in the perfect world where science, reason, free markets and our legal system flawlessly work together. In this case, the government stepped in to protect a public GOOD (public health) from being senselessly destroyed. The government, right or wrong, does this kind of thing all the time in other industries. And, as was previously noted, the existence of the vaccine courts does not preclude pursuing justice elsewhere. Finally, it’s definitely not like vaccine-damaged children are being sent to wait in line next to Gitmo-detainees–waiting in legal purgatory for someone to decide if/when/where a case should be held.

In case any skeptics want to show up, the authors of the anti-vaccine screed “Vaccine Epidemic” are organizing a rally tomorrow in NYC. Below is the press release. They seem to be a bit confused about exactly what they want to protest – the Bruesewitz decision or Bill Gates’ recent remarks. But they seem delusional enough to expect that there are “tens of thousands of outraged parents” who will attend:

FOR IMMEDIATE RELEASE Coalition for Vaccine Safety (CVS) and Autism Advocacy Organizations Contact Louise Kuo Habakus
917-553-4634
Outraged Parents and Advocates Call for Multi-City Protests Against Microsoft Chairman and Billionaire Bill Gates After Being Called âChild Killersâ
Press Conference to Take Place Tomorrow, Thursday, February 24rd at 12:00 Noon Across From Microsoft Executive Offices in Manhattan
(New York, N.Y.) Vaccine safety and autism advocates Louise Kuo Habakus and Mary Holland, Esq. will join other citizens, parents and organizations at a major press conference on Thursday, February 24, 2011 at 12:00 noon to announce the start of a multi-city protest involving tens of thousands of outraged parents of children who have vaccine injury, autism and other chronic disabilities. The protest and press conference against Microsoft founder and Chairman Bill Gates challenges his controversial remarks on national TV that those who question vaccine safety âkill children.” The attendees are demanding an immediate apology from Gates. The press conference will take place outside the Microsoft Executive Offices at 1290 Avenue of the Americas (corner of 52nd Street) in Manhattan. These groups will hold additional protests in Manhattan, Long Beach and Omaha where Gates will be speaking publicly. The Bill and Melinda Gates Foundation has pledged $10 billion over the next decade for global vaccine development, production, and distribution. Although vaccines have contributed to the reduction of some infectious disease, the recommended doses of vaccines for children have exploded. Parents in New York City schools are required by law to give their children 35 vaccines to attend school.
Habakus and Holland are co-editors and authors of recently released book Vaccine Epidemic and both are national leaders in the autism and vaccine safety movement.
When: Thursday, February 24, 2011 12:00 noon Where: Microsoft Executive Offices 1290 Avenue of the Americas (corner of 52nd Street) New York, NY
Organizations supporting this press conference: Age of Autism; Autism One; Center for Personal Rights; and Elizabeth Birt Center for Autism Law and Advocacy (EBCALA).

For once the anti-vaxxers are correct. The decision, for all PRACTICAL purposes closes off access to the civil courts.

Sadly, Socratic Gadfly chose to insult me, rather than spend the few minutes to learn the obvious.

For example, The Orlando Personal Injury Network said

“But did the 1986 law strip plaintiffs of their right to sue drug companies in state court?

Yes it did, ruled the U.S. Supreme Court on Tuesday.”

…Peter H. Meyers, director of George Washington University Law Schoolâs Vaccine Injury Clinic, said the ruling largely eliminates the right of those who suffer vaccine injuries to bring lawsuits in civil court. âThey really will have one essential chance for compensation: the vaccine court,â he said.

And contrast the language of the press release to what they sent to their mailing list, as reproduced on Ginger Taylor’s blog:

Press Conference at Microsoft NYC Headquarters on Feb 24
On Thursday, February 24 at 11:30 am, advocates, parents, and professionals will gather for a press conference at Microsoft’s NYC headquarters at 1290 Avenue of the Americas (52nd Street and Sixth Ave, southeast corner).
Join us for a public display of anger. It is time for a protest that sends a strong and unequivocal message.
We reject Bill Gates’s misguided rhetoric of intolerance against those who question vaccine safety. We demand an apology from Bill Gates for his irresponsible comments on national TV. All human beings, including parents whose children were injured and died from their vaccines, are entitled to speak out about vaccine safety and affirm that vaccination choice is a human right. No one, including our corporate leaders, should be permitted to publicly insult this right.
Vaccine Epidemic Authors Condemn Supreme Court Ruling in Bruesewitz v. Wyeth
Coming on the heels of a successful book launch event in New York City on Feb 18, which gathered over 300 people at the NYU School of Law, we were deeply disappointed yesterday morning to learn of the Supreme Court’s ruling in Bruesewitz v Wyeth. The 6-2 decision forecloses civil lawsuits for vaccine design defects and further tilts the already unfair playing field of the Vaccine Injury Compensation Program, which consistently decides against vaccine-injured famlies after years of venomous litigation.
Justice Sonia Sotomayor wrote a blistering dissent, in which Justice Ruth Bader Ginsburg joined, arguing that the majority appears more concerned about shielding industry than about the welfare of our children, and more concerned with a policy to prevent tort cases alleging vaccine-induced autism from reaching civil court than with the statute’s plain language.
Many safety and autism advocacy organizations have joined to express their condemnation, as reflected by the Coalition for Vaccine Safety’s press release issued yesterday.
Microsoft Chairman Says Vaccine Safety Advocates Are “Killing Children”
Earlier this month, Microsoft Chairman Bill Gates stated on a CNN interview with Dr. Sanjay Gupta that so-called “anti-vaccine efforts” — which are, in truth, efforts to raise science-based concerns about vaccine safety — “kill children.”
Gates’s expression of intolerance was directed at those who voice concern about the wisdom of current vaccination policy and defend their human right to vaccination choice. His statement went unchecked in the mainstream media. It is an undisputable fact that vaccines injure and cause death to some children. Those who fight for vaccine safety seek to lessen these injuries and deaths, not ignore them, as Bill Gates would have people do.
Please join the press conference to help break the silence of vaccine injury and to call attention to the human right to vaccination choice.

All human beings, including parents whose children were injured and died from their vaccines, are entitled to speak out about vaccine safety and affirm that vaccination choice is a human right. No one, including our corporate leaders, should be permitted to publicly insult this right.

So they have the right to “speak out” and no-one has the right to criticize what they say. They sound exactly like whiny religious fundamentalists.

@Sheldon52 and others … no it doesn’t. NOTHING has changed in the standards of judgment for the vaccine court to rule in favor of plaintiffs. NOTHING. Just as Orac said, before you made your first comment, and others made similar first comments. I’m sorry you don’t grasp that fact, but that’s what the fact is.

As for the state court issue nothing’s changed there, either. The original 1986 law precluded suits from starting in state court. Orac also noted this. ALL this ruling did was state that the Court says the 1986 law pre-empts initial state court action on design-defect claims as well as on other claims where initial action at state court level was already pre-empted. So, it stops nothing; rather, it clarifies what was already stopped.

Was the majority’s ruling a proper one? Here’s what 42 U. S. C. Â§300aaâ22(b)(1), the relevant section of the National Childhood Vaccine Injury Act, says:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

Subsection 2 goes on:

For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine.

So, design defects, it seems, were meant to be heard by the court. There is one exception.
Sub-subsection A of subsection 2 says that if a plaintiff shows:

(B)y clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).

In other words, willful negligence suits can still proceed, unless the new ruling invalidated them, too. At the least, that’s how I read the law.

Of course, somebody could bring a willful negligence claim against a vaccine maker and the case get to SCOTUS and even that angle be overturned.

That said, the case at hand did not involve a willful negligence claim.

@ curiosity: I too wondered what the specific allegations did not “prove” their case in the “Vaccine Court”…which has a lower standard of proof than state and federal courts. I was able to get the intermediate case details and decision from the Federal Court 3rd District and commented about it (See my posting at #32 above).

In that posting I drew some conclusions about what I read in the papers and the decision against the plaintiffs which made reference to Wyeth and the whole vaccine manufacturing community not being diligent enough in their research to remove whole cell antigen from the pertussis-diphtheria-tetanus vaccine…the only one available when Hannah received her 3rd DTP at age 24 weeks.

I also pointed out that once DTaP (acellular Pertusis component) was developed, it was not approved for use in infants receiving any of the three primary series of DTP, only approved for booster vaccine in older children. Approval for the primary series of three vaccines diphtheria-tetanus and acellular pertusis antigen was approved 5 years after Hannah received her primary series….many years after Hannah’s parents stated she became autistic.

As I’ve demonstrated before, my views are in line with lawyers acting in vaccine cases.

Perhaps I’m assuming that you understand the issues. There are 3 arguments for suing a vaccine maker.

One, the vaccine was made improperly and the vaccine caused harm. Two, there weren’t proper warnings and the vaccine caused harm. Three, the vaccine was made properly but it wasn’t the bestest vaccine that could have possibly be used.

The statute allowed suing for the first claim, but it is illusory (see below). The statute clearly excluded the second claim, provided the vaccine maker followed the rules.

The issue before the Supreme Court was whether or not bestest(design defect) claims could be heard by courts. The court said no. So if the vaccine was made properly, you can’t sue.

Why is suing if the vaccine is made improperly illusory? Because claims have to go through the vaccine court first and it pays on a no-fault basis. It is very unlikely that petitioners will turn down the award of the vaccine court for the civil court process especially since punitive damages aren’t allowed (except under 23). Or more accurately, plaintiff’s lawyers aren’t going to want to take on cases where punitive damages aren’t allowed.

The Supreme Court judgement didn’t change the usual understanding of the law. After all, the law was passed in 1986 and it took 25 years for a Supreme Court decision. It is the end of the line for the 5000 cases in the OAP.
So as I’ve said before, for all practical purposes there will not be law suits for vaccine claims.

@Sheldon At least you admit SCOTUS “didn’t change the usual understanding of the law.” Guess my words, or your final writing of your own, were small enough for even you to understand.

Otherwise, Orac, I and others have answered your nonsense about “there will not be law suits for vaccine claims.” You yourself admit the vaccine court still allows suits. What it doesn’t allow, of course, is the type of suits the 1986 statute was written to eliminate in the first case.

In short, what you’re saying sounds like you’re a trial lawyer who has just seen one last loophole closed right in your face.

As a left-liberal, I don’t buy conservative hooey about punitive damages run amok. But, I hear a lawyer like you, and I know that that’s why the conservative talking point CAN run amok.

That said, per your website, you say the dissent is stupid, and say nothing about the affirmative. So, don’t claim that I’m confused; you sound like you are. That said, assuming you’re a civil trial lawyer, you may be disappointed with the dissent because it doesn’t dissent for reasons that you as a trial lawyer would most like.

Oh, BTW, as a newspaper editor, I’ve parsed language from lawyers on both sides of civil suits before.

And, if you’re going to use a word like “bestest,” you’re not the person to be claiming control of the English language anyway. The actual word is “best,” so, yes you do need to use shorter word.

It seems to many that uncompensatable layers of injuries may necessarily exist, and the Vaccine Court is not an effective mechanism. Potentially, there are clinically or judicially unrecognized, or subthreshold, vaccine injuries.

Each of these concerns (level of injury too low, ineffective mechanism) is more true of the civil court system than of the Vaccine Court. The Vaccine Court is set up along the lines of a workers compensation system, providing a more efficient process with lower levels of required proof in exchange for removal of non-compensatory damages.

You’ll notice from billboards and radio and TV ads in your home town (if you live in the USA) that the workers compensation system has decidedly not resulted in a dearth of workers compensation claims or attorneys willing to assist with them. I’d expect the same from the Vaccine Court.

pD and others discussing the state-vs-federal angle: I wasn’t aware of any Constitutional aspect to this decision. I thought the Court was just interpreting Congressional intent for the federal law that established the Vaccine Court. Am I incorrect in supposing that?

Erwin Alber is one of the most hilariously nutty antivaxers around. If you haven’t see his page (VINE) it’s definitely worth visiting for a laugh, it is Facebook’s answer to Whale.to.

Erwin learned all he knows about debating from watching Monty Python’s “Argument” sketch. That’s why he can only ever respond to rational discussions the way he did above: by constantly interjecting with “No it isn’t!”

Design defects, in this case, basically means side effects that are inherent in the currently approved vaccine “designs”. It is known that certain side effects, although rare, will manifest themselves, and are not due to the vaccine manufacturers wrongdoing. This is similar to saying that allergic reactions are an inherent “design defect” of making peanut butter, thus we’re not gonnna hold peanut butter makers liable for a person having an allergic reaction to the peanuts in it.

Once again, you don’t bother to research. You look at my blog, but you don’t bother to spend a minute looking at my profile.

First of all, I’m Canadian, Which means that even if I were a small C conservative in Canada (which I’m not), I almost certainly wouldn’t qualify as conservative in the US.

Second, the title of my blog is http://www.vaccineswork.blogspot.com. Most people who think would realize that this is hardly to be the blog of a trial lawyer interested in vaccines. I’m not a trial lawyer. I’m not a lawyer, but I do understand legal issues.

Third, punitive damages in Canada have been capped, currently about $200,000, by the Supreme Court of Canada for personal injury claims for decades. Capping damages for punitive claims (or eliminating them) for vaccine damage cases makes perfect sense to me.

Fourth, I’m actually astonished that someone would point out my use of bestest as if I merely didn’t understand that the normal word is best. I used it twice. When I enter it in the comment here, I see a red line underneath it indicating it isn’t spelled properly.

As a vaccination advocate, my interest was the practical result of the decision going one way or the other. The practical result will be to stop the civil lawsuits (the vaccine court is not a court but a compensation program) from bringing in uncertainty as to the cost of doing business if one distributes vaccines in the United States.

There was a time 6 months ago, when I wrote and posted (Huffington-Post) as you are now as if the language of the legislation allowing lawsuits was all that mattered. But that’s wrong. You have to take into account the practicalities.

I like the result. I thought the dissent was stupid because the result would have been to largely put the US where it was before 1986, except that the failure to warn cases (a really big deal) were eliminated. Vaccine companies were not worried about lawsuits for making the vaccine improperly. It was the ‘design defects’ and jury awards and punitive damages that terrified them.

Overall this discourse with you has demonstrated truly the problems of trying to teach a pig to sing.

Unless you can come up with some particularly good howlers for me to make fun of, that’s where I’ll leave it.

@63 “pD and others discussing the state-vs-federal angle: I wasn’t aware of any Constitutional aspect to this decision. I thought the Court was just interpreting Congressional intent for the federal law that established the Vaccine Court. Am I incorrect in supposing that?”

Yes, you are wrong. I’m Canadian, but the constitutional issue is that the US feds can preempt state law. The question was whether the language of the statute did preempt state law. I’m just happy with the result and don’t care how it effects the doctrine of preemption. But for a view of the issues see http://druganddevicelaw.blogspot.com/2011/02/notes-on-bruesewitz.html from the Drug and Device Blog.

I have not read the entire opinion, but I read the summary at the beginning of the opinion. There were no constitutional issues raised in this case, at least not at the Supreme Court level. It is solely a case having to do with statutory interpretation. In other words, although the preemption clause of the U.S. Constitution gives Congress the power to enact laws that override state law, that was not an issue in this case. The issue was did the statute in fact preempt the type of state tort law claim at issue.

In other words, the issue was not whether Congress *could* preempt state law (constitutional issue), but whether it *did* (statutory interpretation issue).

Why is suing if the vaccine is made improperly illusory? Because claims have to go through the vaccine court first and it pays on a no-fault basis. It is very unlikely that petitioners will turn down the award of the vaccine court for the civil court process especially since punitive damages aren’t allowed (except under 23). Or more accurately, plaintiff’s lawyers aren’t going to want to take on cases where punitive damages aren’t allowed.

Wow! A lot of people have a low opinion of lawyers, but that is probably the most cynical indictment of the entire profession that I have yet seen. So essentially what you are saying is that even though the Vaccine Court guarantees that, win or lose, plaintiff’s lawyers will be fairly compensated for their time, all lawyers are so greedy that no plaintiff will be able to find a lawyer absent the prospect for an enormous payday far in excess of any reasonable wage.

#63 Jud, re (#11, 20 prn)Each of these concerns (level of injury too low, ineffective mechanism) is more true of the civil court system than of the Vaccine Court.
Thank, Jud. I agree on the potential for a Vaccine Court program to improve economic efficiency. The task before the regulators and the vaccine manufacturers is remove as much residual risk and uncertainty as possible. This means to improve their operations so much that public perception improves because of “quality, safety and effectiveness improvement overkill”, not marketing skullduggery and regulatory coercion.

Right now, there is a substantial, growing part of the population that isn’t buying it. Literally.

Possible perceptual breakthrough improvement examples:
1. Predictive biomarkers, ideally lab-on-a-chip at birth
2. Better vaccines. Flu vaccination may yet convert from its annual, or panic-demic, marketing forms, to a more stable offering with longer, broader coverage, and then years of prior experience with the given vaccine.
3. Better administration. Perhaps Clemetson’s positive type recommendations to prevent or abort some kinds of reactions should be reviewed, again.
4. Resolve non-vaccine problems. Nutrition remains mired in politics, and IOM’s recent vitamin D copout probably toasted another big chunk of institutional credibility. What if gross vitamin D deficiency really was part of the autism problem and vaccines were taking the blame?

@Sheldon … I assumed you were Canadian. That doesn’t preclude you from practicing trial law in the US if you’re licensed. Ergo, it wasn’t directly relative.
2. I’m not the “bestest” pig, so I can’t sing yet.
3. Trrl @69l summed up the objection to your claims even better than me. If you’re not a civil trial lawyer, you sure sounds like one. Your fault and problem, not ours. (Note that it’s not just my perception, and maybe you’ll get a clue, though I doubt it.)
4. A system with no punitive damanges vs. one capped at $200K? A difference which makes no difference … ?
5. For the last time, despite your misinterpretation, this did NOT end the right to legal avenues beyond vaccine court. Again, if you keep claiming it did, as trrll pointed out, you sound more and more like a money-chaser. Even if you’re not, again, the perception issue being created is your problem not ours.

Seth Mnookin has an article in today’s Scientific American “The Impossibility of Responsible Nuance in the Vaccine Discussion”. Mnookin relates the history of the whole cell pertusis vaccine and doctor’s experience with post vaccination with the whole cell pertussis vaccine. Young mothers were cautioned about possibility of fever and fever-induced seizures associated with the vaccine BEFORE 1996 when acellular pertussis vaccine was approved by the FDA for the Primary series at 2-4-6 months of age; both of my children born in 1970 and 1976 received whole cell pertussis vaccine for their primary series and for booster immunizations.

Hannah received her 6 month whole cell pertussis vaccine April, 1992 which was the ONLY type of pertussis vaccine recommended for use in the primary series at that time.

The case at hand was first reviewed in the “Vaccine Court” which has a much lower burden of proof and the claim was denied.

A second lawsuit instituted by the child’s parents based on “design” defects was also denied and now the SCOTUS has also re-affirmed the lower court’s ruling.

Mnookin’s article also delves into the politics behind the autism-vaccine link, now totally debunked by umpteen studies in the USA and elsewhere, that muddy the waters for honest debate about the causes of autism.

And, I don’t think statements about the Bush appointments to the SCOTUS vs Obama appointments to the SCOTUS, supposed big business/Republican leanings vs liberal/Democratic leanings have anything to do with this particular blog. Hint; visit the Huffington Post for that forum.

@ sheldon 101 (and on behalf of sheldon 101) I’ve visited your website and enjoy many of your postings on the Huffington Post. I conclude after perusing your many, many postings on the H-P that you are one of the good guys. You certainly have more “staying power” than I do a (I tend to throw up my hands after a few postings). For that, I thank you.

The debate today about the impact of the SCOTUS ruling on public health initiatives to increase vaccine coverage is merely a small squabble amongst posters on this blog. Kinda silly huh…when most of us are on the same page about the effectiveness of vaccines and the truly bogus link between vaccines and the onset of autism. Let’s all enjoy this latest development.

Marilyn Mann #68 is right. No constitutional issues were presented or decided in this case, except indirectly as constitutional issues affect the analysis of legislative intent with respect to express preemption clauses.

I think it’s worth noting that, even if there were no Vaccine Act, in many jurisdictions one would still have to deal with the “unavoidably unsafe” exception to strict product liability as promulgated in the Restatement (Second) of Torts, Section 402A, Comment k. This wasn’t something that Congress or the US Supreme Court made up – it has existed in product liability law since the 1960’s and was imported into the Vaccine Act so that it would apply nationally with respect to vaccines.

@MTS
1. I don’t, in general, trust the wisdom of 12 ordinary citizens. We’re at the point, going by average, that 12 “ordinary citizens” would include a majority of global warming deniers, would probably include a majority of alt-med supporters and other things.
2. Can you find 12 such with a “desire for truth”? Global warming deniers claim green jobs are part of a socialist agenda. Pseudo-med boosters believe in conspiracies by Big Pharma (which, admittedly, has done a bit of leaving that door open).
3. Trial lawyers like John Edwards can “buy” Ph.D.s too. Not only can they, they do. John Edwards probably would have Andrew Wakefield in his bullpen, if he were trying suits today and we didn’t have the vaccine court, given the ethics Edwards has displayed. The “dueling experts” problem in general is one good reason for the vaccine court.

Anne – thanks for the explanation. I went and read the Vaccine Court decision and was disgusted to read how Mark Geier had screwed up. He apparently wrote in his “expert witness” report that Hannah Bruesewitz had died and referred to her autopsy report (Hannah was alive at the time and, so far as I know, is alive today).

One of the “unintended consequences” of the Vaccine Court and its lower standards of expert testimony is that people like Mark Geier can continue to make a living spouting absolute nonsense under oath.

He [Mark Geier] also refers to the VAERS reports regarding arthritic symptoms and hepatitis and rubella vaccines. (Hannah does not have arthritic symptoms; hepatitis and rubella vaccines are not at issue here.)

Oh my.

Petitioners filed Dr. Geierâs fourth report, dated March 22, 2002. P. Ex. 33. Here, inter alia, he discusses the movie âA Beautiful Mindâ as evidence that DPT can cause afebrile seizures because the lead character was administered insulin in order to cause him to have afebrile seizures which was hoped to be a cure of his schizophrenia. Dr. Geier thinks DPT lowered Hannahâs blood sugar, causing afebrile seizures.

Wow.

In his discussion of DPT causing seizures, Dr. Geier refers in his second affidavit to the IOMâs Adverse Effects of Pertussis and Rubella Vaccines (1991), but significantly omits the IOMâs conclusion that DPT does not cause afebrile seizures. Hannah had afebrile seizures.

I wonder if any anti-vaxers will turn on him because of his incompetence in his testimony/affidavits.

I wonder if anyone can come up with a viable proposal for criminalizing willful or reckless promotion of lies about medical subjects…
In some cases, a viable proposal might be achieved with a derivative of Lysenkoism.

You say you aren’t a lawyer but know the law. You may not know as much law as you think you do (at least U.S. law), as your comment @67 makes evident.

Federal preemption of state law is expressly provided for in the Supremacy Clause of the U.S. Constitution. Whether Congress has the Constitutional right/power to preempt state law is thus not open to serious question. Whether, in an individual federal statute, Congress intended to preempt some particular aspect(s) of state law is often at issue. As Marilyn Mann pointed out so well @68, this is a question of statutory rather than Constitutional interpretation.

The reason I raised the question originally is because it seems to me many people think there must be a Constitutional issue in order for a case to come before the Supreme Court, but in fact there are other reasons (bases of jurisdiction) that give the Court the power to take a given case.

The reason I raised the question originally is because it seems to me many people think there must be a Constitutional issue in order for a case to come before the Supreme Court, but in fact there are other reasons (bases of jurisdiction) that give the Court the power to take a given case.

Aha. I believe I likely fit into the classification you describe above. That being said, if another reason is the basis for a taking case, can’t the SC still find whatever law to be Unconstitutional, if they felt that way?

That being said, if another reason is the basis for a taking case, can’t the SC still find whatever law to be Unconstitutional, if they felt that way?

Theoretical answer: Yes, once the Court has jurisdiction, it is empowered to decide all issues fairly presented. If it finds a Constitutional issue that the parties haven’t raised, the Court may go ahead and decide it, if the record is sufficiently developed; it may ask for briefs from the parties to further develop the issue; or it may send the case back to the trial court to develop evidence on the issue if that’s necessary.

Practical answer: The Court by tradition is (supposedly) reluctant to reach Constitutional issues unnecessarily, so if there are other bases for reaching the same decision, the Court will prefer those. (Note that specifically with regard to Bruesewitz, since preemption – the Supremacy Clause – is explicitly part of the Constitution, there was no issue presented regarding constitutionality of the law.)

Political answer: If the Court has alternative bases for reaching a decision but nevertheless decides the Constitutional issue, it is either (1) a matter of fundamental justice, or (2) unwarranted judicial activism, depending on which side you’re on.

I don’t mind being criticized, when it is accurate. My comment #68 wasn’t clear enough and warrants criticism for that.

It didn’t deserve this: “You say you aren’t a lawyer but know the law. You may not know as much law as you think you do (at least U.S. law), as your comment @67 makes evident.”

If you had spent 30 seconds re-reading my comment, instead of going snarky first you would have seen that the problem was wording. Moreover, anyone who decided to criticize the comment should have followed the link I provided, especially when prefaced by “But for a view of the issues” and realized the problem wasn’t my understanding of US law. And just written a clarification comment. That’s what I would have done.

Of the two failings, your is much the greater as it indicates a willingness to be snarky and criticize without bothering to do the slightest of research. This is huge failing of anti-vaxxers, but isn’t confined to them. Me, I research first, especially if I am going to go all snarky.

In 68, I wrote:

“I’m Canadian, but the constitutional issue is that the US feds can preempt state law. The question was whether the language of the statute did preempt state law. I’m just happy with the result and don’t care how it effects the doctrine of preemption. But for a view of the issues see http://druganddevicelaw.blogspot.com/2011/02/notes-on-bruesewitz.html from the Drug and Device Blog.”

Obviously, there is no constitutional issue, but rather the issue of whether or not the statute was effective in preempting state law as anybody who spent a second looking at the link would have seen.

First, sheldon101’s quote of my question: I wasn’t aware of any Constitutional aspect to this decision. I thought the Court was just interpreting Congressional intent for the federal law that established the Vaccine Court. Am I incorrect in supposing that?”

Now, sheldon101’s response: Yes, you are wrong. I’m Canadian, but the constitutional issue is that the US feds can preempt state law.

It could not be more plain that –

(1) I said the issue was not Constitutional, but rather Congressional intent (to preempt or not) in enacting the Vaccine Court law; and

(2) You said I was wrong, i.e., there was a Constitutional issue “that the US feds can preempt state law.”

Once again, I apologize for being less clear than I should have been. In context, it was still pretty clear what I meant. But if it makes Jud happier, I will admit that I was 100% wrong in using the words I did. But that doesn’t change the following:

It didn’t deserve this: “You say you aren’t a lawyer but know the law. You may not know as much law as you think you do (at least U.S. law), as your comment @67 makes evident.”

If you had spent 30 seconds re-reading my comment, instead of going snarky first you would have seen that the problem was wording. Moreover, anyone who decided to criticize the comment should have followed the link I provided, especially when prefaced by “But for a view of the issues” and realized the problem wasn’t my understanding of US law. And just written a clarification comment. That’s what I would have done.

Of the two failings, your is much the greater as it indicates a willingness to be snarky and criticize without bothering to do the slightest of research. This is huge failing of anti-vaxxers, but isn’t confined to them. Me, I research first, especially if I am going to go all snarky.

If you had spent 30 seconds re-reading my comment, instead of going snarky first you would have seen that the problem was wording.

Apparently none of the three people who responded to your comment (myself, Marilyn Mann @68, Anne @76) saw this supposedly obvious meaning of what you wrote. I admit that I did not spend time re-reading what you wrote; hard for me to see that it is the reader’s obligation to spend time carefully looking for meanings at odds with plain wording, rather than the writer’s to spend time carefully writing.

“Snarky” – apparently a favorite expression of yours – no. Just a statement of fact based on the same reading of your comment as everyone else who responded to it. (See the quote under the banner of this blog.)

Moreover, anyone who decided to criticize the comment should have followed the link I provided, especially when prefaced by “But for a view of the issues” and realized the problem wasn’t my understanding of US law.

I did that. It did nothing to clarify that when you said “Yes, you are wrong” you meant I was correct, or when you said “the constitutional issue is that the US feds can preempt state law” you really meant there was no constitutional issue.

But I suppose we have reached the point of repetition and diminishing returns here, so at least for me, on to more interesting stuff.

Matthew Cline,
I remember one thing in the Omnibus Autism Proceedings. Geier had submitted his fees to the Court. The sum was over $200,000. The Special Master basically tore him to shreds. To summarise: “This is not a valid item, neither is this, and nor is this. Also you are overcharging for this, that, and those.” The Special Master awarded him just over $20,000, or approx 10% of what he claimed.

I’m flabbergasted. You actually followed the link and didn’t understand where I went wrong. That’s hard to believe as the discussion has nothing to do with constitutionality, but all about the complexities of various court invented preemption doctrines.

I guess I was wrong. You weren’t lazy, just couldn’t comprehend simple English.

I, for one, am glad the SCOTUS decided the way it did. In an ideal world an cases of postulated harm from a vaccine would be decided in a court of law by 12 jurors using the best of scientific information and evidence. Unfortunately, this has not been the case in the past. Time and again we have seen outrageous awards for conditions or “harm” that could not have been the fault of the manufacturer/defendant. ($10 million dollar cup of McDonalds coffee anyone?)

And, to be fair, it is not as if those who believe that their children have been harmed by a vaccine have NO recourse. They can take their claims to the Vaccine Court, where they are held to a MUCH lower standard of proof. (As in , “Did the damage occur within a month of the vaccine? Is it on the list of known problems with said vaccine? Is it in [i]any way possible[/i] that the vaccine caused the injury? Award to Plaintiff!!”)

It is not like the court hasn’t been ‘paying out’ either. “Since 1988, the no-fault process has led to almost $2 billion in compensation to more than 2,500 families.” Simply math says that rounds out to about $800K per case. Not exactly chicken feed.

If the SCOTUS had not ruled the way they had, every Tom, Dick, and Harry would be coming out of the woodwork to drown the vaccine makers in litigation. Just hiring lawyers to answer all of the claims would end vaccine production in this country.

The decision reached is the only common sense alternative the SCOTUS had.

The problem is that study after study has proven the vaccines DON’T cause autism. And anti-vaxxers just can’t live with that truth.

That being said, and having finished reading the court log, I think this case was decided poorly.

Correct me if I’m mistaken, but didn’t Hannah’s case really boil down to whether or not the child had a fever when admitted to the ER?

If her temp (which may have been masked by a dose of tylenol the mother gave her a few hours earlier) had been 101.1F, then she would have had a febrile seizure and she would have prevailed. Also, because the nurse used an underarm measurement, instead of the ‘gold standard’, the temp could only have a top range of 100.8 or so. This single measurement decided the case by making the seizure afibrile, thus not caused by the vaccine. *facepalm*

No common sense was used to determine if the tylenol suppressed the fever, the nurse may have just taken a ‘poor’ reading, etc. Ugh.

It is pretty abhorrent to say, in effect, “We cannot be absolutely sure the vaccine caused the injury because the seizures were not of the type listed,” (even though it is reasonably possible that they were) and deny recompense, when a study of the vaccine itself said there would be these very kind of seizures in 1 out of 310,000 cases.

Just to set the record, I am a big fan of vaccines. I’ve raised six kids, all of them fully immunized, and on schedule, every one. (Except for the Gardisil for my 12 yr old. I’ll wait until she reaches the age that they actually trialed it on, thankyouverymuch.) But this particular case looks like it was decided poorly.

My reading of the ruling was that Hannah only maybe fit a definition of a febrile seizure which was 23 years old and no longer used by anybody. She didn’t come anywhere vaguely close to qualifying as febrile by any modern definition.

So yes, it was important whether the seizures were febrile or not, but it wasn’t exactly a close call or technicality that they were ultimately considered not.

The question of encephalopathy was arguably even more important, but she apparently only fit THAT diagnosis by defining encephalopathy as “any disease of the brain.” The more detailed testimony as to what symptoms are actually expected in REAL encephalopathy again indicated that Hannah wasn’t even close.

Federal preemption of state law is expressly provided for in the Supremacy Clause of the U.S. Constitution. Whether Congress has the Constitutional right/power to preempt state law is thus not open to serious question. Whether, in an individual federal statute, Congress intended to preempt some particular aspect(s) of state law is often at issue. As Marilyn Mann pointed out so well @68, this is a question of statutory rather than Constitutional interpretation. Houston injury attorney